• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Journal of Oriental Neuropsychiatry
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• v.34 no.3
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• pp.247-257
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• 2023

Objectives: To analyze the trend of Korean patents of natural product extracts for depression. This study also aimed to enhance the development and application of natural product extracts for depression in Korean herbal medicine. Methods: We searched the Korea Intellectual Property Rights Information Service and Science ON to collect Korean patent data of natural product extracts for depression. Two authors independently screened and assessed full texts of screened patents for eligibility. Included patents were analyzed both quantitatively and qualitatively. Results: A total of 62 patents from 2002 to December 2021 were included for analysis. The number of patents has constantly increased since 2002. Glycyrrhiza uralensis Fischer, Perilla frutescens Britton var. acuta Kudo, Zizyphus jujuba Miller var. inermis Rehder were frequently used among 62 patents. Alcohol extraction was mostly used, followed by water extraction and ethyl extraction regarding extract methods. Eight patents were herbal medicine used for treating depression in Korean Medicine. Conclusions: Various Korean herbal medicine and minerals were used as natural-products for treating depression. These results provide fundamental data that can be used for inventing new patents using Korean herbal medicine, developing new natural product extracts for depression, and extending the range of application of these products in clinical setting.

• Herbal Formula Science
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• v.17 no.2
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• pp.111-121
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• 2009

Objectives : This study was performed to evaluate the efficacy of ampule containing herbal extract(Ulmus davidiana, Ginkgo biloba, Perilla ocymoides, Morus alba, Glycyrrhiza uralensis (licorice), and Angelica gigas) on skin wrinkles in adult women with facial wrinkles. Methods : A total of 12 women, 30 to 46 years of age, with wrinkles in the corner of eyes, applied ampule containing herbal extract twice daily for up to 12 weeks. Silicon replicas of right crow's feet area and antecubital fossa were taken before use of test product and at 4, 8 and 12 weeks. The replicas were analyzed by optical profilometry with Skin Visiometer SV600. The wrinkle and roughness parameters, R1, R2, R3, R4 and R5 were calculated and statistically analyzed. In addition, a subjective evaluation of product efficacy was conducted by patient's assessment. Results : The mean values of all the skin roughness parameters were decreased at 4-week, and decreased significantly at 8 and 12-week except R4 at 12-week after test product use. The subjective evaluation of wrinkle by patient's assessment was also improved. However, one patient noted stiffness of face after use of test product. Conclusions : These study suggested that the application of ampule containing herbal extract twice daily for 12 weeks may effectively improve the facial wrinkles without severe side effect.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• Natural Product Sciences
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• v.6 no.2
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• pp.79-81
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• 2000

Investigation of the fruits of Chaenomeles sinensis (Rosaceae) resulted in the isolation of a minor flavonoid. The structure of flavanone glycoside was determined to be as $2-hydroxynaringenin-7-O-{\beta}-glucoside$ on the basis of FAB-MS and spectral evidence, especially by 2D-NMR $(^1H-^1H\;COSY,\;HMQC,\;HMBC\;and\;NOESY)$.

• The Korea Journal of Herbology
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• v.29 no.3
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• pp.35-42
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• 2014

Objectives : Since single extract powders was released at 1987, the insurance fee has not been changed, but the price of raw material has been increasing. According to this, Pharmaceutical company couldn't invest on quality of the product, so, the quality of single extracts went down and lost the consumer's trust. We checked the contents of marker ingredients in single extract thereby to recover the reliability of insurance-covered herbal preparations. Methods : we bought total twelve products of eight different single extracts of two main pharmaceutical companies among total 65 kinds of single extract powder stipulated in KHP (The Korean Herbal Pharmacopoeia) monograph III at Jan. 2013. Assays of selected single extract powders are performed by KHP regulation. And we surveyed price fluctuation of relevant herb raw materials from 2005 to 2012. Results : Among twelve products, eight single extract powders were suitable by the KHP regulation. But four products didn't reach the content amount of KHP. Marker contents in the single extracts product of Pueraria Root, Licorice, Peony root and Scutellaria Root of A company were 70%, 1%, 23.7% and 75.1%, respectively. Conclusions : We can acertain whether there's a quality problem in the insurance-covered single extract powders. But, A company is no longer producing these improper single extract powders. As a medicine, single extract powders needs to be strictly quality controlled by the company, and regularly monitored by the KFDA.

• Journal of Society of Preventive Korean Medicine
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• v.12 no.3
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• pp.9-20
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• 2008

The purpose of this study is to investigate the actual conditions of herbal medicine products for the establishment of drug utilization review system. To accomplish of the purpose, we investigated medical treatment pay of insurance and consumption of herbal medicine products in pharmacy at jeollabuk-do, two oriental hospital etc. To gain valid and reliable the actual conditions of herbal medicine products, it needed close relationship with oriental hospital, society for manufacture of herbal medicines etc and further study classify herbal medicines by Korean Medicine.

• Korean Journal of Oriental Medicine
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• v.12 no.1
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• pp.13-22
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• 2006

Background and Aims: Herbal drugs and traditional medicines have lately attracted considerable attention by global pharmaceutical corporations because the conventional chemical drugs didn't work well for many chronic diseases or intractable diseases. The government of Korea is also supporting to develop the new drug which is high value added product, and the natural medicine including herbal medicine(or Traditional Korean Medicine) have a significant presence in this field. non-clinical pharmacology/toxicology study and clinical trial are the two major criteria which estimate efficacy and safety for registration of new drugs. All of the pharmaceutical companies producing herbal medicine and the academic and the academic world of Tradition Korean Medicine have the will to develop new herbal drugs, but there are obstacles that they have neither experience nor guideline about clinical trial. Therefore for developing new herbal drugs, it is necessary to research the present conditions and comprehensive systems about clinical trial in Northeast Asian countries China, Taiwan and Japan because they have the common background with Korea in traditional medicine fields. Methods : The present state of clinical trial for herbal medicine in Korea was investigated. And then, those in China, Taiwan, Japan was also investigated. Results and conclusions : There are significant differences among 4 Southeast Asian countries Korea, China, Taiwan and Japan each in present condition, purpose, involved comprehensive system including legislation, and actual operation of clinical trial for traditional medicine.

• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.3
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• pp.755-759
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• 2007

In this study, we screened twenty four extracts of eight medicinal plants and three extracts of the commercial product for their antimicrobial and antioxidant properties. Ethanol and ethyl acetate extracts were found active where as aqueous extracts were little or no active. Extracts of Sophora flavescens, Salvia miltlorrhiza and Glycyrrhiza uralensis showed strong activity againsttested organisms and could be the potential antimicrobial agent. The increase of antimicrobial and antioxidant activities of formulations might be due to synergic effect. The results also indicated that the activity of bamboo salt and herbal products can be enhanced by making appropriate formulations.

• The Journal of Korean Medicine
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• v.40 no.1
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".